Prostate Cancer Patient Management With 18F-DCFPyL PET/CT

Overview

This is a multi-center, single-arm, open-label, phase III trial in patients with biopsy-proven prostate cancer. Patients will receive regular standard of clinical care. The only study-specific procedures will the administration of 18F-DCFPyL followed by a PET/CT scan. Differences in theoretical optimal clinical management based on a review of clinical, biochemical and radiographic subject data before and after 18F-DCFPyL PET/CT imaging by a central panel of experts will be captured at study completion.

Full Title of Study: “Differences in Optimal Prostate Cancer Patient Management as Proposed by a Panel of Experts Before and After 18F-DCFPyL PET/CT”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2027

Detailed Description

Objectives: The primary objective of this study is to assess the differences in theoretical optimal clinical management afforded by 18F-DCFPyL PET/CT in prostate cancer patients as proposed by a central panel of experts. Primary endpoint: 1. Differences in theoretical optimal clinical management based on a review of clinical, histopathological, biochemical and radiographic subject data both before and after 18F-DCFPyL PET/CT imaging retrospectively by a central panel of experts. Secondary endpoints: 1. 18F-DCFPyL PET/CT scan positivity fraction in patients with biochemically recurrent prostate cancer, stratified by PSA. 2. Immediate AE up to 90 minutes post-administration of 18F-DCFPyL.

Interventions

  • Diagnostic Test: 18F-DCFPyL PET/CT
    • 18F-DCFPyL Positron Emission Tomography/Computed Tomography Scan

Arms, Groups and Cohorts

  • Experimental: 18F-DCFPyL PET/CT
    • 18F-DCFPyL PET/CT Scan

Clinical Trial Outcome Measures

Primary Measures

  • Differences in optimal clinical management
    • Time Frame: 30 days
    • Differences in theoretical optimal clinical management based on a review of clinical, histopathological, biochemical and radiographic subject data both before and after 18F-DCFPyL PET/CT imaging retrospectively by a central panel of experts.

Secondary Measures

  • Scan positivity fraction in BCR by PSA.
    • Time Frame: 30 days
    • 18F-DCFPyL PET/CT scan positivity fraction in patients with biochemically recurrent prostate cancer, stratified by PSA.
  • Adverse events
    • Time Frame: 2 hours
    • Immediate AE up to 90 minutes post-administration of 18F-DCFPyL.

Participating in This Clinical Trial

Inclusion Criteria

  • Male sex – Age 18 years or older – Previously diagnosed with prostate cancer, under referring physician's care – ECOG performance status 0 – 3, inclusive – Able to understand and provide written informed consent – Able to tolerate the physical/logistical requirements of a PET/CT scan including lying supine (or prone) for up to 40 minutes and tolerating intravenous cannulation for injection Cohort A – High risk staging (HRS): Staging of high risk not previously treated patients as defined by any one of the following: – Gleason score > 7 – Serum PSA > 15 ng/ml – T stage of T3 or greater on TNM staging – Equivocal/inconclusive conventional staging such as CT, MRI or bone scan – Clinical suspicion of advance stage disease (e.g. bone pain) Cohort B – Biochemical recurrence: Restaging of biochemically recurrent prostate cancer patients as defined by increasing serum PSA on serial measurements and current PSA above 0.1 ng/ml following any treatment for prostate cancer. Exclusion Criteria:

  • Patients who are medically unstable (e.g. acute cardiac or respiratory distress or hypotensive) – Patients who exceed the safe weight limit of the PET/CT bed (usually approximately 400 lbs.) or who cannot fit through the PET/CT bore (usually approximately 70 cm diameter) – Patients with unmanageable claustrophobia

Gender Eligibility: Male

Only patients with prostate cancer are included.

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Sir Mortimer B. Davis – Jewish General Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Stephan Probst, MD, Chief of Nuclear Medicine – Sir Mortimer B. Davis – Jewish General Hospital

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